A Companion Sample Collection Protocol to Support the Discovery of Breast Cancer Aberrations With Treatment of CDK4/6 Therapy/LEE011/Ribociclib
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ClinicalTrials.gov Identifier: NCT03050398 |
Recruitment Status :
Terminated
(GCP issues.)
First Posted : February 10, 2017
Results First Posted : May 15, 2020
Last Update Posted : May 28, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer | Drug: Ribociclib Drug: letrozole | Phase 3 |
This was a multicenter, non-treatment based companion sample collection protocol conducted in the US only. This protocol sought to evaluate the aberrations of common pathways for newly diagnosed HR+/HER2- advanced breast cancer tumors and responses to ribociclib in diverse patient populations. This companion sample collection protocol was available for all US patients enrolled on CLEE011A2404 (CompLEEment-1) and did not alter the planned treatment. Tumor collection required for this study occurred at two time points: at baseline/screening and upon the development of progressive disease as shown in the protocol. Patients eligible for this companion study were required to sign an optional additional consent form at the time of enrolling into the core trial.
After eight patients had consented and samples had been taken, it was determined that the companion study protocol had not been properly initiated or monitored at the sites. This was determined to be a significant GCP violation and the clinical team made the decision to terminate the trial. In addition to the GCP issues, enrollment had been closed to the core study so enrolling additional patients was no longer possible. The limited number of samples would not provide any meaningful analysis. The samples were never analyzed. The study was not terminated due to safety or efficacy concerns. Samples collected were either destroyed or will be retained for up to 15 years based upon the decision of the patient.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 8 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | A Companion Sample Collection Protocol to Support the Discovery of Breast Cancer Aberrations With Treatment of CDK4/6 Therapy/LEE011/Ribociclib |
Actual Study Start Date : | June 7, 2017 |
Actual Primary Completion Date : | March 8, 2019 |
Actual Study Completion Date : | March 8, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: ribociclib + letrozole
ribociclib with letrozole per the core study
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Drug: Ribociclib
ribociclib + letrozole Drug: letrozole ribociclib + letrozole |
- Identify Mutations of Genes From Tissue Samples Between Baseline and Time to Progression to Determine Modes of Resistance to Ribociclib After Disease Progression [ Time Frame: Baseline, time of progression approximately 24 months ]Mutations of genes that were relevant to HR+ and the CDK4/6 pathway such as but not limited to CCND1, CDKN2A, PIK3CA and PTEN to identify the potential mechanisms of progression.
- Compare the Differences in Mutations Across Various Races / Ethnicities Based on Baseline Samples [ Time Frame: Baseline, time of progression approximately 24 months ]Change in mutations would have been assessed based on baseline samples and compared across diverse races/ethnicities with HR+ HER2- advanced breast cancer - specifically Caucasian, African America, Hispanic, Native American and Pacific Islander.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Written informed consent was to have been obtained prior to any baseline/screening procedures.
- Patients eligible for this companion sample collection protocol sample collection protocol must have met all inclusion in CLEE011A2404.
Exclusion Criteria:
- Patients eligible for this companion sample collection protocol must not have met any of the exclusion criteria in the CLEE011A2404 study, in addition to the following:
- Patients without either fresh or archival tumor tissue accessible.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03050398
United States, Arizona | |
Arizona Oncology Associates PC HAL | |
Sedona, Arizona, United States, 86336 | |
United States, California | |
Pacific Shores Medical Group SC | |
Long Beach, California, United States, 90813 | |
United States, North Carolina | |
Oncology Speciialists of Charlotte | |
Charlotte, North Carolina, United States, 28207 | |
United States, South Carolina | |
McLeod Center for Cancer Treatment and Research | |
Florence, South Carolina, United States, 29506 | |
Carolina Blood and Cancer Care of South Carolina | |
Rock Hill, South Carolina, United States, 29732 | |
United States, Washington | |
PeaceHealth St Joseph Medical Center | |
Bellingham, Washington, United States, 98225 |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Documents provided by Novartis ( Novartis Pharmaceuticals ):
Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT03050398 |
Other Study ID Numbers: |
CLEE011AUS42 |
First Posted: | February 10, 2017 Key Record Dates |
Results First Posted: | May 15, 2020 |
Last Update Posted: | May 28, 2020 |
Last Verified: | May 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
HR-positive HER2-negative Advanced breast cancer LEE011 ribociclib letrozole femara CDK CDK4 CDK6 |
CDK4/6 CDK4/6 inhibitor Phase III Phase IIIb ER-positive PR-positive Postmenopausal Premenopausal Men |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Letrozole Antineoplastic Agents Aromatase Inhibitors |
Steroid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |